Randomised comparison of three weight control programmes during adjuvant treatment for early breast cancer (Breast - Activity and Healthy Eating After Diagnosis)

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast; Cancer; Breast cancer

• Registration Number: ISRCTN68576140
• Lead Sponsor: South Manchester University Hospital (UK)

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28110564 results 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31366999/ results (added 28/05/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-31
• Study Completion: 2012-02-02
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 480

Inclusion Criteria

1. Within 10 weeks of primary surgery for primary breast cancer (invasive or in-situ)
2. Pre and postmenopausal women of any age able to undertake interventions
3. Any weight, as programmes aim to tackle existing weight problems and prevent weight gain in healthy weight women
4. Receiving/due to start adjuvant chemotherapy, radiotherapy or endocrine therapy or no adjuvant treatment
5. Early breast cancer stages I - III
6. Ability to understand written instructions and have completed baseline 7 day diet and exercise diaries
7. Resident within Greater Manchester only in order to maximise uptake and retention to interventions and study
8. Written informed consent
9. Females, no specified age limit

Exclusion Criteria

1. Metastatic or inoperable disease
2. Physical/psychiatric condition which impairs compliance or mobility assessed from medical history by recruitment nurse or verified from baseline fitness assessment by the trial physiotherapist, i.e.:
2.1. Insulin requiring diabetes, as diet and physical activity changes would require close coordination with the treating physician. Non-insulin requiring diabetics are eligible for the study.
2.2. Serious digestive and/or absorptive problems, including inflammatory bowel disease
2.3. Cardiovascular, respiratory (determined from recent pre-operative electrocardiogram [ECG], chest X-ray) disease
2.4. Musculoskeletal disease or joint problems
2.5. Psychiatric disorders or conditions, e.g., untreated major depression, psychosis, substance abuse, severe personality disorder
3. Women who regularly take daily medication known to effect body composition, e.g., corticosteroids (women receiving 2 - 3 days steroids with chemotherapy may be included)
4. Patients with metal implants, ie hip prosthesis are excluded from the study as this precludes DXA measurement of body fat (breast implants, pacemakers are not excluded)
5. Women who have received neoadjuvant chemotherapy or endocrine
6. Patients considering reconstruction surgery in the next 12 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified